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▼ This medicinal product is subject to additional monitoring. Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in Google Play or Apple App Store. Adverse events should also be reported to Ipsen via email at pharmacovigilance.uk-ie@ipsen.com or phone on 01753 627777.

IQIRVO®▼ (elafibranor) therapeutic indication1

IQIRVO is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.1

PBC Today

PBC Today

Many patients remain at risk of disease progression despite treatment2–4

Potential risk factors

Factors like race, age, disease severity, and presence of symptoms can increase risk of disease progression5–12

Potential risk factors

Non-response of treatment

ALP is not adequately controlled in up to 40% of patients treated with UDCA*2–4

Non-response of treatment

Second-line treatments are needed to manage PBC progression and lessen symptom impact13

To date, second-line treatments:

May have incomplete effects, with limitations in managing the underlying cholestasis and inflammation of PBC12,14,15

May worsen PBC symptoms, such as pruritus, to the point of causing treatment discontinuation12,14

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Footnotes
*Exact values depend on the response criteria used, and include the Barcelona, Paris I, Paris II, Mayo, Toronto, GLOBE, PBC-UK, and Rotterdam criteria2-4

Abbreviations
ALP, alkaline phosphatase; PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid.

References

  1. IQIRVO® (elafibranor) Summary of product characteristics (SmPC). 2024.
  2. Trivedi HD et al. Frontline Gastroenterol. 2017;8(1):29–36.
  3. Invernizzi P et al. Dig Liver Dis. 2017;49(8):841–846.
  4. Hirschfield GM et al. Expert Rev Gastroenterol Hepatol. 2021;15(8):929–939.
  5. Corpechot C et al. Clin Res Hepatol Gastroenterol. 2022;46(1):101770.
  6. Carbone M et al. Gastroenterology. 2013;144(3):560–569. e7.
  7. Peters MG et al. Hepatology. 2007;46(3):769–775.
  8. Cholankeril G et al. Clin Gastroenterol Hepatol. 2018;16(6):965–973. e2.
  9. Galoosian A et al. Dig Dis Sci. 2020;65(2):406–415./li>
  10. Sayiner M et al. Hepatology. 2019;69(1):237–244.
  11. European Association for the Study of the Liver. J Hepatol. 2017;67(1):145–172.
  12. Lindor KD et al. Hepatology. 2019;69(1):394–419.
  13. Barba Bernal R et al. Turk J Gastroenterol. 2023;34(2):89–100.
  14. Levy C. Clin Gastroenterol Hepatol. 2023;21(8):2076–2087.
  15. Montano-Loza AJ & Corpechot C. Clin Gastroenterol Hepatol. 2021;19(11):2241–2251.
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